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Improving the Approach to and Management of the Older Patient With Metastatic Gastric Cancer

Primary Purpose

Metastatic Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Didactic Session
Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Metastatic Gastric Cancer

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ability to read and understand English, ability to sign consent, and complete a self-assessment evaluation.
  2. Evidence of mGC (mGE junction cancer allowed). Patients can be enrolled at any stage of their treatment or disease course.
  3. Ongoing active therapy for mGC. Patients can be treated with any type of therapy including chemotherapy, immunotherapy or Her-2 targeted therapy.
  4. Life expectancy ≥3 months.

Exclusion Criteria:

  1. ≤69 years old.
  2. Inability to read and understand English.
  3. No evidence of mGC.
  4. Not on active therapy.
  5. Life expectancy <3 months.

Sites / Locations

  • Fox Chase Cancer CenterRecruiting
  • Temple University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Provider Didactic Intervention

Arm Description

Phase 1 - Providers complete a needs assessment questionnaire, which evaluates the approach to older mGC patients at each site. Phase 2 - Providers participate in an hour-long didactic session and begin enrolling eligible metastatic gastric cancer (mGC) patients. Enrolled mGC patients complete a comprehensive geriatric assessment (CGA). Providers complete the treatment plan and review of geriatric assessment questionnaires, which also includes an evaluation of their overall view of the utility of the geriatric assessment. Phase 3 - Follow-up chart reviews (2-3 months post intervention) are completed to assess for actual implementation of recommended interventions identified by the geriatric assessment.

Outcomes

Primary Outcome Measures

Number of geriatric abnormalities detected. (Tool used: Comprehensive Geriatric Assessment)
Investigators will test the proportions of patients having at least one abnormality detected by the Comprehensive Geriatric Assessment that was missed in the standard clinical assessment compared to a null-hypothesis rate of 5%. The Comprehensive Geriatric Assessment includes the following scales: Eastern Cooperative Oncology Group Performance Status, Self-rated Performance Status, Katz Activities of Daily Living scale, Lawton Instrumental Activities of Daily Live Scale, Timed Up and Go, Number of Falls in past 6 months, Medical Social Support Scale, Geriatric Depression Scale, National Comprehensive Cancer Center Distress Thermometer, Blessed Orientation Memory Concentration Scale, Charlson Comorbidity Index, Body Mass index,Mini Nutritional Assessment, Cancer and Aging Research Group Chemotherapy Toxicity Prediction Calculator, Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy scale
Percentage of treatment plan changes. (Count # of treatment changes 2-3 months after comprehensive geriatric assessment. Site coordinators will complete follow-up chart review of each patient to see what, if any, changes were made)
Investigators will assess the percentage of physician reported cases whose treatment plan was modified due to responses on the Comprehensive Geriatric Assessment.

Secondary Outcome Measures

Provider perception (Review of Geriatric Assessment Questionnaire)
Measurement of provider perception of the efficacy and feasibility of the didactic educational session via questionnaire
Fitbit assessed functional status. Fitbit data: step count
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between step count, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Fitbit assessed functional status. Fitbit data: distance logged
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between distance logged, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Fitbit assessed functional status. Fitbit data: moderately active, lightly active, and sedentary minute categorization.
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between moderately active, lightly active, and sedentary minute categorization, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Fitbit assessed functional status. Fitbit data: floors climbed
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between floors climbed, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Fitbit assessed functional status. Fitbit data: calories burned
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between calories burned, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Fitbit assessed functional status. Fitbit data: heart rate
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between heart rate, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.

Full Information

First Posted
November 2, 2020
Last Updated
February 13, 2023
Sponsor
Fox Chase Cancer Center
Collaborators
National Comprehensive Cancer Network, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04618809
Brief Title
Improving the Approach to and Management of the Older Patient With Metastatic Gastric Cancer
Official Title
Improving the Approach to and Management of the Older Patient With Metastatic Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Comprehensive Cancer Network, Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to enhance the care of older metastatic gastric cancer (mGC) patients by increasing awareness among oncology providers of the unique aspects of care required for older patients. The goal of the study is to educate providers on the utility of geriatric assessment in guiding therapy of older mGC patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include four phases.
Detailed Description
Older oncology patients pose a significant treatment challenge due to poor chemotherapy tolerance as a result of underlying co-morbidities, lack of social support, and diminished functional reserve. Oncologists are faced with the challenge of differentiating between patients that can and cannot tolerate chemotherapy, and tailoring therapy to the patient's biologic rather than chronologic age. A significant challenge that surrounds the treatment of the older metastatic gastric cancer (mGC) patient in particular, lies in the lack of evidence based clinical data to guide the oncologist in determination of a treatment plan. This is a result of under representation of older patients in clinical trials. Due to these challenges, a thorough evaluation of the older patient is recommended prior to initiation of anti-cancer therapy. The purpose of this research study is to enhance the care of the older mGC patient by increasing awareness among oncology providers of the unique aspects of care required for older patients. The goal of the study is to educate providers on the utility of geriatric assessment in guiding therapy of older metastatic gastric cancer patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include four phases: Needs assessments - to understand the population of older gastric cancer patients seen in routine practice at community and academic centers, and assess their treatment approach. Educational programming about management of older metastatic gastric cancer patients, and geriatric assessment of these patients. Active testing of the use of geriatric assessment in clinical practice, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status. Short-term follow-up chart reviews (2-3 months post intervention) to assess for actual implementation of recommended interventions identified by the geriatric assessment. The ultimate goal is to expand this educational intervention to other oncology practices beyond those participating in this study, and for all older cancer patients regardless of their disease site. During this study period we will identify the specific gaps that exist in each practice for the care of older patients with mGC. This information is crucial to understand the needs of this patient population and will inform future trials with possible intervention. The second phase of our study will expose the practices to the use of a geriatric assessment through a patient's self-assessment tool and demonstrate its feasibility. Our hope is that all involved practices will find benefit from incorporating a geriatric assessment into their practice and will continue to use it in the future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Gastric Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Provider Didactic Intervention
Arm Type
Experimental
Arm Description
Phase 1 - Providers complete a needs assessment questionnaire, which evaluates the approach to older mGC patients at each site. Phase 2 - Providers participate in an hour-long didactic session and begin enrolling eligible metastatic gastric cancer (mGC) patients. Enrolled mGC patients complete a comprehensive geriatric assessment (CGA). Providers complete the treatment plan and review of geriatric assessment questionnaires, which also includes an evaluation of their overall view of the utility of the geriatric assessment. Phase 3 - Follow-up chart reviews (2-3 months post intervention) are completed to assess for actual implementation of recommended interventions identified by the geriatric assessment.
Intervention Type
Behavioral
Intervention Name(s)
Didactic Session
Intervention Description
This session will include an overview of the approach to and management of older mGC patients patients through a case-based presentation.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.
Intervention Description
The Comprehensive Geriatric Assessment (CGA) is a composite of assessment scales evaluating physical, psychological, and social well-being, and is the recommended tool for evaluating an older cancer patient and determining appropriateness of therapy. The patient will receive a FitBit TM to wear for 4 days. Number of steps/day will be recorded.
Primary Outcome Measure Information:
Title
Number of geriatric abnormalities detected. (Tool used: Comprehensive Geriatric Assessment)
Description
Investigators will test the proportions of patients having at least one abnormality detected by the Comprehensive Geriatric Assessment that was missed in the standard clinical assessment compared to a null-hypothesis rate of 5%. The Comprehensive Geriatric Assessment includes the following scales: Eastern Cooperative Oncology Group Performance Status, Self-rated Performance Status, Katz Activities of Daily Living scale, Lawton Instrumental Activities of Daily Live Scale, Timed Up and Go, Number of Falls in past 6 months, Medical Social Support Scale, Geriatric Depression Scale, National Comprehensive Cancer Center Distress Thermometer, Blessed Orientation Memory Concentration Scale, Charlson Comorbidity Index, Body Mass index,Mini Nutritional Assessment, Cancer and Aging Research Group Chemotherapy Toxicity Prediction Calculator, Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy scale
Time Frame
18 Months
Title
Percentage of treatment plan changes. (Count # of treatment changes 2-3 months after comprehensive geriatric assessment. Site coordinators will complete follow-up chart review of each patient to see what, if any, changes were made)
Description
Investigators will assess the percentage of physician reported cases whose treatment plan was modified due to responses on the Comprehensive Geriatric Assessment.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Provider perception (Review of Geriatric Assessment Questionnaire)
Description
Measurement of provider perception of the efficacy and feasibility of the didactic educational session via questionnaire
Time Frame
18 months
Title
Fitbit assessed functional status. Fitbit data: step count
Description
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between step count, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Time Frame
18 months
Title
Fitbit assessed functional status. Fitbit data: distance logged
Description
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between distance logged, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Time Frame
18 months
Title
Fitbit assessed functional status. Fitbit data: moderately active, lightly active, and sedentary minute categorization.
Description
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between moderately active, lightly active, and sedentary minute categorization, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Time Frame
18 months
Title
Fitbit assessed functional status. Fitbit data: floors climbed
Description
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between floors climbed, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Time Frame
18 months
Title
Fitbit assessed functional status. Fitbit data: calories burned
Description
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between calories burned, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Time Frame
18 months
Title
Fitbit assessed functional status. Fitbit data: heart rate
Description
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between heart rate, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment. We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to read and understand English, ability to sign consent, and complete a self-assessment evaluation. Evidence of mGC (mGE junction cancer allowed). Patients can be enrolled at any stage of their treatment or disease course. Ongoing active therapy for mGC. Patients can be treated with any type of therapy including chemotherapy, immunotherapy or Her-2 targeted therapy. Life expectancy ≥3 months. Exclusion Criteria: ≤69 years old. Inability to read and understand English. No evidence of mGC. Not on active therapy. Life expectancy <3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Efrat Dotan, MD
Phone
215-214-4283
Email
Efrat.Dotan@fccc.edu
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efrat Dotan, MD
Phone
215-214-4283
Email
Efrat.Dotan@fccc.edu
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juhi Mittal, MD
Phone
267-563-1580
Email
Judi.mittal@tuhs.temple.edu

12. IPD Sharing Statement

Learn more about this trial

Improving the Approach to and Management of the Older Patient With Metastatic Gastric Cancer

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